Multinational phase 2b trial of TAR-200 for BCG-unresponsive high-risk non-muscle-invasive bladder cancer

TAR-200 is a first-in-class intravesical drug-releasing system designed to provide sustained delivery of gemcitabine in the bladder. The multinational phase 2b SunRISe-1 trial evaluated TAR-200 alone or in combination with the PD-1 inhibitor cetrelimab for patients with bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer ineligible for or refusing radical cystectomy. TAR-200 monotherapy was well tolerated, with a high complete response rate, durable responses, and prolonged disease-free survival. TAR-200 monotherapy offered a more favorable risk-benefit profile versus TAR-200 plus cetrelimab.